The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Non-mydriatic Retinal Camera, Model Cr6-45nm.
| Device ID | K980246 |
| 510k Number | K980246 |
| Device Name: | NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Glenn Impal |
| Correspondent | Glenn Impal CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-23 |
| Decision Date | 1998-05-06 |
| Summary: | summary |